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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06307496
Other study ID # Pro00133913
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date July 2025

Study information

Verified date March 2024
Source Medical University of South Carolina
Contact Kinsey Pebley, PhD, MPH
Phone 843-779-5794
Email pebley@musc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the current study is to pilot the efficacy, feasibility, and acceptability of an evidence-based smoking cessation intervention adapted for cancer patients and delivered via video. Investigators aim to assess if this intervention is considered acceptable by participants, feasible to implement, and effective at increasing knowledge about smoking cessation before conducting a fully powered clinical trial.


Description:

A randomized controlled pilot study is being conducted to test the acceptability and feasibility of a smoking cessation intervention tailored for cancer patients that is delivered via video. Participants will be in a video intervention or control group that receives information about quitting smoking. Participants will complete surveys prior to randomization, and will complete additional surveys one week, one month, and three months post-randomization to provide their thoughts about the videos, information about changes to smoking behaviors, and knowledge about quitting smoking.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date July 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 or older - Diagnosed with cancer (any type) - Receiving care at Medical University of South Carolina - Reads and understands English language - Currently smoking cigarettes (any amount) Exclusion Criteria: - Unstable or poorly managed medical or psychiatric conditions that impair cognition and ability to provide informed consent (e.g., dementia, active psychosis).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Smoking cessation intervention
Receive links to smoking cessation videos
Informational intervention
Receive NCI's "Clearing the Air" booklet

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina Alliance NCORP Research Base Cancer Control Program

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability Acceptability will be measured using the Acceptability of Intervention measure, which contains four items with answer options on a scale from 1-5, with higher scores indicating higher acceptability. We will consider the intervention "acceptable" if an average score of 4 or higher is obtained. 1 week post-randomization
Primary Feasibility Feasibility will be measured using the Feasibility of Intervention measure, which contains four items with answer options on a scale from 1-5, with higher scores indicating higher feasibility. We will consider the intervention "feasible" if an average score of 4 or higher is obtained. 1 week post-randomization
Primary Retention Rates We will determine if there are differences in retention rates between intervention groups. 1 week, 1 month, and 3 months post-randomization
Secondary Changes in knowledge about quitting smoking We will assess changes in knowledge about tools to quit smoking and the role of nicotine, etc. from prior to randomization (before the intervention is delivered) to post-randomization follow-ups. These questions will be generated by the study investigators based on video content. Baseline, 1 week, 1 month, and 3 months post-randomization
Secondary Changes in smoking behaviors We will assess the number of 24-hour quit attempts and 7-day point prevalence at 1 week, 1 month, and 3 month follow-ups. 1 week, 1 month, and 3 months post-randomization
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